Medical Device Registration and Approval in Indonesia

General country-specific regulatory information is provided on this page for medical device registration and approval in Indonesia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Indonesia, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Indonesia

REGULATORY AUTHORITY: Medical devices are regulated by the Indonesian National Agency of Drug and Food Control (NA-DFC).

CLASSIFICATION SYSTEM: Risk Based Classification: Classes I, IIa, IIb and III.

TIMEFRAME: The registration process takes 45 working days for Class I devices, 90 working days for Class IIa and IIb devices, and 120 working days for Class III devices.

LICENSE VALIDITY: Licenses issued in Indonesia expire after 5 years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

Other Southeast Asian Countries:

Cambodia, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam